RoslinCT and Ayrmid Pharma Ltd. Plan Strategic Partnership for Omisirge® Manufacturing
Ayrmid Pharma Ltd., a pioneering company in cell therapy focused on transforming cells into powerful therapeutics, and RoslinCT, a world-leading contract development and manufacturing organization (CDMO) specializing in cell and gene therapies, have announced their intent to enter into a strategic partnership for the production of Omisirge® (omidubicel-onlv). Omisirge is a commercial cell therapy product used for the treatment of hematologic malignancies, currently marketed in the United States by Gamida Cell Inc., a subsidiary of Ayrmid Pharma Ltd.
Under the proposed agreement, RoslinCT will undertake the technology transfer and commercial-scale manufacturing of Gamida Cell’s Omisirge. This innovative cell-based therapy, which consists of nicotinamide-modified allogeneic hematopoietic progenitor cells, received FDA approval in 2023 and has since been made available to patients in the U.S. The technology transfer and production activities are expected to be conducted at RoslinCT’s cutting-edge cell therapy current good manufacturing practice (CGMP) facility in Hopkinton, Massachusetts, which is specifically designed to support commercial manufacturing of advanced therapeutic products.
A Strategic Move to Enhance Manufacturing Capabilities
Omisirge is an advanced cell therapy designed to improve outcomes for patients with hematologic malignancies undergoing stem cell transplantation. By modifying allogeneic hematopoietic progenitor cells with nicotinamide, the therapy enhances the engraftment process and immune reconstitution, potentially reducing the risk of infection-related complications following transplantation. The therapy provides an important alternative source of stem cells for patients lacking a fully matched donor, filling a crucial gap in the treatment of blood cancers.
Ayrmid Pharma Ltd. and RoslinCT have both recognized the necessity of expanding manufacturing capabilities to meet the growing demand for Omisirge and ensure a robust supply chain. This partnership aims to leverage RoslinCT’s specialized expertise in cell therapy manufacturing to provide a scalable, reliable, and high-quality production process.
Dual Sourcing Strategy to Ensure Supply Chain Resilience
As part of a global dual sourcing strategy, Ayrmid Pharma Ltd. intends to work with RoslinCT to transition Omisirge production to the latter’s Massachusetts facility. This move is expected to enhance manufacturing flexibility, reduce supply chain risks, and provide additional capacity for production scaling as demand increases.
Dr. Joe Wiley, Chief Executive Officer of Ayrmid Pharma Ltd., emphasized the importance of this partnership, stating:
“As part of our global dual sourcing strategy, we are delighted to announce that we intend to work with RoslinCT on the technology transfer of Omisirge to their state-of-the-art facility in Hopkinton, MA. This key strategic move will allow Gamida Cell to source Omisirge for our patients from both our internal manufacturing capability and RoslinCT.”
With the increasing need for cell and gene therapies in oncology and hematology, having multiple manufacturing sites will provide added assurance for physicians and patients relying on Omisirge as a treatment option. The dual sourcing strategy aligns with industry best practices in ensuring continuity of supply and mitigating risks associated with single-source production.
RoslinCT’s Expertise in Advanced Cell Therapy Manufacturing
RoslinCT is a leading CDMO with extensive experience in developing and manufacturing cell and gene therapies for both clinical and commercial applications. Their Hopkinton, MA facility is designed to support large-scale cell therapy production while maintaining stringent regulatory compliance, including adherence to U.S. FDA CGMP standards and other global regulatory frameworks.
Peter Coleman, Chief Executive Officer of RoslinCT, expressed enthusiasm about the planned partnership, stating:
“The dynamic interactions between the two teams are very productive, and we look forward to working with the Ayrmid Pharma Ltd. and Gamida Cell Inc. teams to support the production of this innovative product for their patients in the United States. We’re delighted about the intent to partner with Gamida Cell and add this product to the portfolio of commercial products manufactured at RoslinCT.”
RoslinCT’s facility has been purpose-built to accommodate the complex requirements of cell-based therapies, ensuring high levels of quality control, scalability, and efficiency. By bringing Omisirge into their commercial manufacturing portfolio, RoslinCT is further strengthening its position as a premier CDMO in the cell and gene therapy space.
Addressing the Growing Need for Hematologic Cancer Treatments
Hematologic malignancies, including leukemia, lymphoma, and myeloma, pose significant challenges in treatment, particularly when patients require stem cell transplantation. A key issue in this field is the limited availability of fully matched donors, which can delay or prevent timely transplantation. Omisirge addresses this challenge by providing a modified alternative donor source that improves engraftment speed and immune recovery.
The FDA approval of Omisirge in 2023 was based on compelling clinical data demonstrating its ability to shorten neutrophil recovery times and reduce the risk of infection-related complications compared to standard cord blood transplantation. Since its launch, Omisirge has provided new hope to patients and healthcare providers seeking more effective and accessible transplantation options.
The Road Ahead: Technology Transfer and Commercialization
The technology transfer process between Ayrmid Pharma Ltd. and RoslinCT will involve multiple stages, including knowledge sharing, process validation, and regulatory approvals. Given the complexities of cell therapy manufacturing, this transition will be carefully managed to ensure product consistency and regulatory compliance.
The two companies aim to complete the technology transfer and initiate commercial production at RoslinCT’s Hopkinton facility within the next year. Once fully operational, this partnership will not only increase Omisirge’s manufacturing capacity but also reinforce the overall resilience of its supply chain, ensuring continued availability for patients in need.
